PRINTER'S NO. 3826
No. 2623 Session of 2002
INTRODUCED BY FRANKEL, CORRIGAN, COSTA, CREIGHTON, CRUZ,
FREEMAN, HARHAI, JOSEPHS, MANN, McGEEHAN, MELIO, PALLONE,
PISTELLA, SCRIMENTI, SOLOBAY, THOMAS, TURZAI, WANSACZ,
WASHINGTON, J. WILLIAMS AND YOUNGBLOOD, MAY 6, 2002
REFERRED TO COMMITTEE ON HEALTH AND HUMAN SERVICES, MAY 6, 2002
AN ACT
1 Amending the act of September 26, 1951 (P.L.1539, No.389),
2 entitled, as amended, "An act defining clinical laboratory;
3 regulating the operation of the same; requiring such
4 laboratories to obtain permits, and to be operated under the
5 direct supervision of qualified persons; imposing certain
6 duties upon the Department of Health; and providing
7 penalties," providing for the use of home tests by
8 physicians.
9 The General Assembly of the Commonwealth of Pennsylvania
10 hereby enacts as follows:
11 Section 1. The act of September 26, 1951 (P.L.1539, No.389),
12 known as The Clinical Laboratory Act, is amended by adding a
13 section to read:
14 Section 11.2. Use of Point-of-care and At-home Testing
15 Equipment by Physicians.--(a) Notwithstanding any other
16 provision of law, a private physician may utilize in his office
17 laboratory any point-of-care or at-home testing equipment that
18 is available to a patient if all of the following conditions are
19 met:
20 (1) The physician's office laboratory must be licensed by
1 the Bureau of Laboratories and directed by a physician.
2 (2) The personnel of the physician's office laboratory must
3 be trained according to manufacturer's recommendations to use
4 the equipment.
5 (3) The physician's office laboratory may perform testing
6 only on the patients of the physician or those of the practice
7 and may not receive specimens from other offices or
8 laboratories.
9 (4) The physician's office laboratory shall use materials
10 that are in date and are stored and used according to the
11 manufacturer's directions.
12 (5) The physician's office laboratory shall have written
13 procedure manuals or follow supplemental package inserts
14 supplied by the equipment manufacturer.
15 (6) All quality control tests conducted by the physician's
16 office laboratory shall be done in accordance with
17 manufacturer's directions and recorded in a quality control log
18 book.
19 (7) All results of the laboratory tests of a patient shall
20 be entered in the patient's chart.
21 (b) The Bureau of Laboratories may perform an onsite
22 examination of the physician's office laboratory when point-of-
23 care or at-home testing is initiated and every two years
24 thereafter or in lieu of the onsite examination, a self-
25 evaluation questionnaire may be sent to the physician's office
26 laboratory which shall be completed by the physician's office
27 laboratory and returned to the Bureau of Laboratories.
28 Section 2. This act shall take effect in 60 days.
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